Rystiggo (rozanolixizumab-noli)

No dosing information is available for this tab.

Rozanolixizumab-noli is administered via subcutaneous infusion. The drug is available as a colorless to pale brownish-yellow, clear to slightly opalescent solution in single-dose vials containing rozanolixizumab-noli 280 mg/2 mL (140 mg/mL).

Rozanolixizumab-noli should only be prepared and infused by a healthcare provider. It should be administered using a subcutaneous infusion pump that has the ability to pre-set the administered volume, as each vial of rozanolixizumab-noli contains excess volume for priming the infusion line. The manufacturer recommends the following criteria for administration of rozanolixizumab-noli: syringe pump occlusion alarm limits at the maximum setting; administration tubing length <=61 cm; and infusion set with a needle of 26 gauge or larger. Refer to instructions from the infusion pump manufacturer for full preparation and administration information.

Unopened rozanolixizumab-noli vials should be stored at 2-8degreesC in the original carton to protect from light until time of use; do not shake or freeze. To prepare rozanolixizumab-noli for administration, allow vials to reach room temperature for approximately 30 minutes. Do not use heating devices. If needed, unopened vials may be stored at room temperature (up to 25degreesC) for a single period of up to 20 days in the original carton to protect from light. Once a vial has been stored at room temperature, it should not be returned to refrigeration.

Infuse rozanolixizumab-noli within 4 hours of puncturing the vial and immediately after priming the infusion set. Use transfer needles to fill a syringe with rozanolixizumab-noli, then remove the needle from the syringe and attach the infusion set to the syringe. Follow manufacturer instructions to prepare the infusion pump and prime the tubing. Choose an infusion site in the lower right or lower left part of the abdomen, below the navel; do not infuse where skin is tender, bruised, red, or hard, and avoid infusing into tattoos, scars, or stretch marks. Rotate infusion sites for subsequent administrations.

Infuse rozanolixizumab-noli at a constant flow rate, up to 20 mL/hour. Do not flush the infusion line when the infusion is complete, as the volume of infusion has been adjusted to account for losses in the line.

If a scheduled dose is missed, the missed dose may be administered up to 4 days after the scheduled time point. Then, resume the regular dosing schedule until the treatment cycle is completed.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug-drug interaction studies have been performed with rozanolixizumab-noli. Rozanolixizumab-noli is not metabolized by cytochrome P-450 (CYP) enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of CYP enzymes are unlikely.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Neonatal Fc Receptor Inhibitors/Insulin Efsitora Alfa

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Insulin efsitora alfa is fused to IgG2. When bound to FcRn, degradation of insulin efsitora alfa is inhibited, reducing its renal clearance and prolonging its action.(3) FcRn inhibitors bind to FcRn and may decrease systemic exposure of other ligands of FcRn, like insulin efsitora alfa.(3)

CLINICAL EFFECTS: The effectiveness of insulin efsitora alfa may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of insulin efsitora alfa states that if an FcRn inhibitor is required, an alternative basal insulin should be considered.(3)

DISCUSSION: FcRn inhibitors may decrease concentrations of insulin efsitora alfa.(3)

Rozanolixizumab-Noli/Igg Antibodies And Derivatives

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

*None.

There are no contraindication contraindications for this drug.

• Infection

There are no moderate contraindications for this drug.

The most common adverse effects (observed in >=10% of patients) reported with rozanolixizumab-noli are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.

More Frequent

• Infection

Less Frequent

• Angioedema
• Upper respiratory infection

Rare or Very Rare

• Herpes zoster
• Non-infective meningitis

More Frequent

• Diarrhea
• Fever
• Headache disorder
• Hypersensitivity drug reaction
• Nausea

Less Frequent

• Acute abdominal pain
• Arthralgia
• Injection site sequelae
• Skin rash

No enhanced messaging available.

The safety and effectiveness of rozanolixizumab-noli have not been established in pediatric patients.

There are limited data on rozanolixizumab-noli use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. When rozanolixizumab-noli was administered to pregnant monkeys at doses greater than those used clinically, increases in embryonic death, reduced body weight, and impaired immune function were observed in the absence of maternal toxicity.

A registry that monitors outcomes in women exposed to rozanolixizumab-noli during pregnancy has been established. In order to collect information related to the pregnancy exposure, clinicians or patients may contact 1-844-599-2273 or email ucbcares@ucb.com. Clinicians may inquire about becoming a member of the MGBase registry (https://www.mgbase.org).

There are no data on the presence of rozanolixizumab-noli in human milk; the effects on the breast-fed infant and on milk production are also unknown. Maternal IgG is known to be present in human milk. Consider the developmental and health benefits of breastfeeding, along with the mother's clinical need for rozanolixizumab-noli and any potential adverse effects on the breast-fed child from the drug or the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of rozanolixizumab-noli did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger adult patients.